Data collection process
All instruments consist of online-administered self-report questionnaires which can be accessed remotely on the foster carers’ own devices (computer, phone or tablet). A researcher that is blind to study arm will be available to assist with completion of self-report measures by telephone, if required. In this case, participants will be asked not to disclose their group allocation to the researcher. In exceptional cases, and subject to ethical approval in the light of COVID-19 restrictions, participants who would rather complete the measures offline, in private and at their own pace will be able to complete paper versions of measures to be returned to a member of the research team who will enter it onto the database (if COVID-19 restrictions allow).
Data will be collected at baseline (immediately prior to the intervention), four months post-baseline and 12 months post-baseline. It is anticipated that a significant proportion (around 70%) of identified children will be with the same foster carer at both the four- and 12-month follow up points [43]. Although it is possible that placements may have changed since the initial programme, we have confidence that follow-up data can be collected in the majority of cases even if the nominated child has moved to a new placement. Previous experience has established that it is possible to successfully seek consent from new foster carers to provide follow-up data [39].
Participants will be asked to complete the foster carer demographic form and study baseline measures before randomisation takes place.
Data collection instruments / Outcome measures
Unless otherwise indicated, all study measures have established validity and reliability, and are widely available. Specific study measures are available from the corresponding author.
Primary outcome measure
Child emotional and behavioural wellbeing will be measured by the Strengths and Difficulties Questionnaire (SDQ; [33]), which is a routinely used clinical tool completed by caregivers and designed to assess emotional and behavioural difficulties in children aged between three and 17 years. It was used in the preliminary evaluation and feasibility study [29], and is recognised as the UK government's preferred measure of well-being for children in care. The SDQ consists of 25 closed‐ended questions and an impact supplement, which assesses the extent to which mental health problems have had an impact on aspects of the child’s life. Each item is rated using response categories of “Not-true”, “Somewhat true”, and “Certainly true”. The 25 items are scored across five (five-item) subscales: Conduct problems, Emotional problems, Hyperactivity, Peer problems, and Prosocial. For all the subscales, apart from the prosocial subscale, higher scores are designed to indicate that there are greater levels of difficulty. A total difficulties scale is generated by summing all of the scales except for the prosocial scale.
Secondary outcome measures
Parental stress will be measured using the Parenting Stress Index – Short Form (PSI 4-SF; [34]), which is a self-report measure comprising 36 items using a five-point Likert scale; designed to assess perceived stress in the parenting role. The 36 items are divided into three 12-item subscales; Parental distress, Parent-child dysfunctional interaction, and Difficult child, which combine to form a total perceived stress score. Higher scores on these scales, and on the total stress score, are meant to reflect greater difficulties, with a score of 90 and above (on both the total score and sub-scales) falling within the 'clinical' range.
The Parental Reflective Functioning Questionnaire (PRFQ; [37]) will be used to measure the carers’ capacity for reflective functioning in their caregiving role. The PRFQ is an 18-item questionnaire including three main subscales: Pre-mentalizing, which assesses non-mentalizing of the child, or inability of the parent to acknowledge their child’s mental states, Certainty about mental states, which measures how certain caregivers are about the mental states of their child and their ability/inability to recognise the opacity of mental states, and Interest and Curiosity, which is designed to measure parental interest and curiosity in their child’s mental states.
High scores in Pre-mentalizing and Certainty about mental states reflect reduced capacity for reflective functioning, and high scores in Interest and Curiosity represent increased reflective functioning.
The Professional Quality of Life Questionnaire (PRoQOL) [35] will be used to measure foster carer compassion fatigue and burnout. The PRoQOL is a 30 item self-report measure of the positive and negative effects of working with people who have experienced extremely stressful events. Items are scored using a Likert-type scale where 1 = Never and 5 = very often. The PRoQOL contains three subscales measuring Compassion Fatigue, Burnout and Compassion Satisfaction.
The Emotion Regulation Checklist (ERC; [36]) will be used to assess the carer’s view of a child’s emotions (e.g., emotional lability, intensity, flexibility, and situational appropriateness). The ERC consists of 24 items scored using a four-point Likert-type scale, where 1 = Never and 4 = Always, designed to be completed by an adult who knows the child well, such as a parent or carer. The measure has two subscales: Lability/Negativity (15 items), which is designed to assess emotional intensity, expression of negative emotions, arousal and reactivity, and lability of mood, and Emotion regulation (8 items), which measures adaptive regulation, such as socially appropriate displays of emotion, empathy and emotional understanding. Higher scores on the Lability/Negativity scale reflect greater dysregulation, while higher scores on the Emotion regulation scale indicate a higher capacity for emotion regulation.
Carer Defined Problems Scale (CDPS; [38]): is a measure adapted from the Goal Based Outcome Measure (GBO; [44,45]). The measure asks carers to rate and record up to three problems at the beginning of the intervention (‘Please List below, in order of priority, three problems you have with your child that you would most like help with. Then rate the severity of the problem at present by indicating a number from 0 to 10’). In this version, adapted for online use, changes on the scale is rated by participants on a scale from 0 (no longer a problem) to 10 (couldn’t be worse). The outcome is the amount of movement along the scale from the start to the end of the intervention. Evidence from Briskman and colleagues (2012) has indicated that this measure is highly sensitive to change for foster carers reporting on identified problems with the ‘target’ children they are considering in relation to a parenting-based intervention [46].
The Placement Stability Log has been developed for use in this study, and will be used to collect data relating to changes of social worker, change of school or placement change and reasons for any change. The Placement Stability Log asks carers to report when there has been any significant events or changes relating to the child’s placement. It asks about any changes to the child’s foster placement and if so, where to and the reasons why. Lastly it asks about foster child related events.
Data from this measure will be used to track placement stability and inform collection of follow-up measures e.g. if a child has moved placement.
Economic evaluation measures
Child Health Utility 9 Dimensions (CHU9D) [41]. A paediatric generic, preference-based measure of health-related quality of life, to be completed by the carer. The CHU9D covers nine dimensions (worried, sad, annoyed, tired, pain, sleep, daily routine, work, able to join in activities), each rated on five levels, and can be used to generate Quality Adjusted Life Years (QALYs) for use in cost-utility analysis.
Child and Adolescent Service Use Schedule (CA-SUS). Service-use data will be collected using an adapted version of the CA-SUS, a measure originally designed for young people in mental health populations, but which has been adapted and successfully implemented in a range of health and social care-based studies[47][48]. The version we will use was designed and tested for use with children in care in an earlier feasibility study [39,40] and an online, self-report version is now being developed. The CA-SUS will be completed remotely by carers at baseline, covering the previous three months, and at both follow-ups (four- and 12-months post-baseline), covering the period since last assessment. The CA-SUS will be reviewed at the end of the Pilot Phase and has been adapted to ensure coverage of remote on-line and telephone delivery of services, given the changes to service delivery as a result of Covid-19 restrictions.
Other measures
Foster carer demographics form. Basic demographic information about foster carers will be collected at baseline using the Foster carers demographics form. This 15-item questionnaire will ask foster carers to provide information about themselves (e.g. Age, gender, ethnic background, educational history and marital status); their fostering history, and demographic and fostering history of the child in their care.
Fostering team site profile questionnaire (SPQ). Service characteristics of local authority’s will be collected at the beginning and end of the trial period via a Fostering team profile questionnaire. This 16-item questionnaire will gather information which characterises services, including: numbers of children placed in foster care, numbers of registered foster carers, and associated interpreting services, and existing foster caring policies, training and support programmes in place. Data from this measure will allow researchers to identify changes in the service between pre- and post-intervention.
Facilitator evaluation
As part of the embedded process evaluation (see below), facilitator adherence will be measured using the Reflective Fostering Programme Facilitator Adherence Rating (FAR) (Unpublished tool): a 14-item observation-based assessment, covering the key components of the Reflective Fostering Programme, used to assess facilitators’ adherence to the Programme.
Interview schedule (Foster carer interviews)
An interview schedule will be used to guide semi-structured interviews with foster carers as part of the process evaluation. The interview schedule will include the following topics:
- Experience of being a foster carer
- Experience of receiving the intervention/usual support
- The Reflective Fostering Programme (Intervention arm only)
- The type of fostering support received (control arm only)
- Wider experiences of taking part in the study
Topics and discussions may vary slightly depending on what group the foster carer was allocated to. Interviews are expected to take no longer than one hour.
Topic guide (Focus groups with facilitators)
Focus groups with facilitators will take place to understand experiences of programme delivery, including co-delivery by carers and social workers; and how the wider context of local authorities influenced intervention delivery. A topic guide has been developed to elicit conversation and ensure all essential topics are covered in the focus group. Topics to be covered include:
- Facilitator experiences of delivering the Programme
- Usefulness of the Reflective Fostering Programme training
- The Reflective Fostering Programme
- Experiences of co-delivery
- Weekly supervision
- Wider experiences of taking part in The Reflective Fostering Study
Focus groups are expected to take no longer than 1.5 hours.
Plans to promote participant retention and complete follow-up {18b}
All participants will be provided with a username and password (unique to them) so they can sign into the database and complete the study measures. Foster carers will be automatically reminded by text, email or phone call to complete the assessments by the research team, and will be followed up in the same way, if necessary, to encourage completion. Those participants unable to complete the study measures online will complete these with a member of the research team by telephone. If they cannot be completed by telephone, participants will be provided with paper copies to complete and return (if COVID-19 restrictions allow). This will ensure that participants who might not be confident in using technology will still be able to complete the measures.
Participants who withdraw from the intervention will be asked to continue to provide outcome data.
For participants who discontinue with the intervention or study, a study withdrawal form will be completed detailing how the participant communicated their wishes to withdraw, type of withdrawal, date, reasons (if obtained), and any discussion regarding withdrawal.
Data management {19}
Data will be entered under each participant’s Participant ID (PID) onto the central database, stored on servers based at NCTU by members of the Study Team working within each research site, and collected at the time-points indicated in the Trial Schedule. Randomisation of participants will also be implemented within this database.
Data collection, data entry and queries raised by a member of the Study Team will be conducted in line with the NCTU and trial specific Data Management processes. Identification logs, screening logs and enrolment logs will be kept at the trial site in a locked cabinet within a secured room. Electronic copies of these logs will be kept on the Investigator Site Files which will be password protected. All data will be handled in accordance with the Data Protection Act 2018.
Access to the database will be via unique, individually assigned (i.e. not generic) usernames and passwords and only accessible to members of the study team, and external regulators if requested. Functional access within the database will be controlled and limited by role and, where appropriate, by site. This access to the study database is controlled and administered by NCTU Data Management. The servers are protected by University of East Anglia (UEA) firewalls and anti-virus products and are patched and maintained (including back-ups) according to best practice. The physical location of the servers is environmentally controlled and protected by CCTV and security door access.
Participant identifiable data will be stored in the database to enable participants to be contacted by site staff for the purpose of sending questionnaires. There will be a clear logical separation of participant identifiable data from the trial data (i.e. by user/role permissions and by data collection instrument).
The database software provides a number of features to help maintain data quality, including; maintaining an audit trail, allowing custom validations on all data, allowing users to raise data query requests, and search facilities to identify validation failure/ missing data.
After completion of the study, the database will be retained on the servers of NCTU for on-going analysis of secondary outcomes. The study database and associated design documentation will be routinely archived for a period of five years unless otherwise advised by the Trial Management Group (TMG). Note that all identifying information such as email addresses will be removed prior to archiving.
Confidentiality {27}
Confidentiality and anonymity will be ensured throughout the study. For those in the intervention arm, participants may discuss sensitive matters during recorded sessions; and any participants may discuss sensitive matters during interviews or focus groups. This will be managed through close attention to confidentiality. The reporting of results (including quotations) will be fully anonymised and excerpts will only be used with the explicit consent of participants.
The study staff will ensure that the participants’ anonymity is maintained. The participants will be identified only by a Participant ID number on all study documents and any electronic database. Additionally, participant identifiers required for automated communication (including email address and mobile telephone number) will also be stored in the database, but logically separated from study data by interface and permission constraints. All documents will be stored securely and only accessible by study staff and authorised personnel. The study will comply with the Data Protection Act 2018, which requires data to be anonymised as soon as it is practical to do so.
Following the Caldicott Principles; only data to be used in analysis relevant to the study and to facilitate running the study will be collected, limited to the surveys and demographic material to be used for data analysis, and contact details for electronic communication. All participants will be identified by a unique ID code that will only be linkable to their name via a password encrypted excel file. Only a limited number of researchers will have access to the link between participant names and ID numbers.
An electronic CRF will be produced. Each participant will have a corresponding CRFs unique to them. CRFs will not bear the participant’s name. The participant’s initials, date of birth and study PID will be used for identification on the database. Access to the database will be managed by NCTU and will be restricted and controlled to authorised personnel and will be password protected. The audit trail will be monitored regularly for any unauthorised access. It is the responsibility of the CI/Site Lead(s) to ensure that relevant personnel are delegated to carry out data collection and data entry. The delegation log will identify all those personnel with responsibilities for data collection and handling, including those who have access to the trial database.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Not applicable, no samples collected.